Ondibta
Insulin glargine biosimilar developed by Gan & Lee Pharmaceuticals. Reference product Lantus.
Brands by market: Ondibta (EU) · Commercial partner or holder: Sandoz (EU)
FDAnot listed
EMAJan 2026authorised
CDSCOnot listed
EDEnot listed
Status by market
FDA
United States
Not listed by FDA.
EMA
European Union · Ondibta
European Medicines Agency and European CommissionApprovedBrand
Ondibta
Holder or applicant
Sandoz GmbH
Pathway
Centralised (Article 10(4))
Approved
Jan 2026
Application or permission
EMEA/H/C/006136
Presentations
see SmPC
Source
S017
CDSCO
India
Not listed by CDSCO.
EDE
United Arab Emirates
Not listed by EDE.
Chronology
- EMAJan 2026Authorised by the European Commission
Sources
S017EMA, medicines data table (medicines-output-medicines-report_en.xlsx) Primary (regulator)
Planning insulin glargine biosimilar development?
EvySaif can help assess your regulatory pathway, clinical evidence requirements and market-entry strategy across India, UAE and other target markets.
Talk to a biosimilar regulatory consultantData current to September 2026.